Baxter ($BAX) is recalling four models of its Automix automated nutrition compounder systems, warning that a keypad malfunction could cause the device to improperly dose patients. The error could lead to serious injury or death, according to the FDA, and the agency tagged the recall with its most serious label.
Baxter informed its customers of the voluntary recall on July 13, warning that spilling fluids on Automix's keypad could cause the device to malfunction and put patients at risk. Baxter asked its customers to stop using the devices immediately and transition to something from a list of replacements the company provided. The company issued a reminder on Aug. 22, and the FDA tagged the recall a Class I on its website Wednesday.
The clinical devices are designed to mix various parenteral solutions and administer them to patients, but if water or other liquid gets on their keypads, they may pump fluids when not programmed to do so, stop compounding before they're done or administer improperly mixed solutions, Baxter said. That could lead to fatal misdosing, according to the FDA, and the agency is asking patients and physicians to report adverse events through its online MedWatch system.
Covered in the recall are the Automix, Automix Plus, Automix 3+3 and Automix 3+3 with Accusource Monitoring System, Baxter said. All of the devices were manufactured between November 1982 and December 2007, and Baxter is seeking to get all of them off the market by June 1, 2013.
- here's Baxter's recall notice (PDF)
- check out the FDA's Class I disclosure
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